Title of Manuscript: Development and Internal-external Validation of a Comprehensive Model for Predicting Risk of Post-RFA Recurrence in HCC Patients

NCT06577272 | Recruiting

• 1 other identifier: IIT20240340B-R1
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background A predictive model for post radiofrequency ablation (RFA) recurrence in patients with Hepatocellular carcinoma (HCC) that incorporates variables like sleep quality and psychological factors can provide more time to prevent the recurrence. Our aim is to investigate the relationship between these factors and post-RFA recurrence, and to construct a predictive model includes these highly preventable factors. Methods We collected data from HCC patients who underwent RFA for the first time from January 1, 2015, to July 2023, assessing their sleep quality, anxiety, and depression levels. We employed Restricted cubic splines (RCS), mediation analysis, Cox proportional hazards model, Elastic network Cox proportional hazards, Competitive risk model to ascertain the relationship between these factors and post-RFA recurrence. We then constructed a predictive model incorporating these factors, and evaluated the model's performance through internal and external validation datasets partitioning by time period.

Conditions

Hepatocellular Carcinoma

Keywords

Sleep quality; Psychological factors; Restricted cubic splines; Cox proportional hazards; Competing risks regression

Outcome Measures

Primary Outcomes (1)

• The Self-Rating Anxiety Scale (SAS)24 was used to investigate the anxiety levels of patients

  It consists of 20 questions, and the sum of all responses represents the raw total score. The raw total score is multiplied by 1.5 to obtain the standard total score. A standard total score of ≥50 is used to diagnose anxiety. The Self-Rating Depression Scale (SDS)25 was used to assess the depression levels of patients. It also consists of 20 questions, and the sum of all responses represents the raw total score. Similar to the SAS, the raw total score is multiplied by 1.5 to obtain the standard total score. A standard total score of ≥53 is used for diagnosing depression.

  This study prospectively collected patients diagnosed with HCC from 2015 to 2023 according to the diagnostic criteria in China's guidelines for Primary liver Cancer Diagnosis and Treatment

Study Arms (2)

post-RFA recurrence

post-RFA did not recurrence

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We identified candidate predictor variables associated with the risk of post-RFA recurrence of HCC patients in clinical or epidemiological literature combined with expert opinion.

You may qualify if:

• ① Diagnosed as primary HCC according to the diagnostic criteria for primary liver cancer in China; ② Either a solitary tumor with a diameter less than 5 cm or 2-3 tumors each with a maximum diameter less than 3 cm; ③ RFA as the initial treatment; ④ Agreed to participate in the study and submitted the completed questionnaire survey; ⑤ A follow-up period exceeding 6 months after ablation.

You may not qualify if:

• ① Vascular invasion or extrahepatic metastasis before ablation; ② Presence of intractable ascites or hepatic encephalopathy; ③ Severe hepatic and renal dysfunction or other substantial organ disorders; ④ Active infections before or after ablation; ⑤ A history of other malignancies; ⑥ Failure to submit a completed questionnaire survey; ⑦ Lost to follow-up before reaching an outcome.

Sponsors & Collaborators

• Tian'an Jiang: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Jiang tianan, Dr

CONTACT

+86 18857127666; tiananjiang@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the ultrasound department

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

CN (1)